Status:
RECRUITING
A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Metabolic Dysfunction-Associated Steatotic Liver Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associa...
Eligibility Criteria
Inclusion
- Have liver fat content ≥8%
- Have ELF score of ≥9 and ≤10.8 at screening
- Have VCTE LSM ≥10 kilopascal (kPa) and \<20 kPa at screening
Exclusion
- Have any other type of liver disease other than MASLD
- Have a body mass index (BMI) \<25 kilogram per square meter (kg/m2)
- Prior decompensated liver disease (history of esophageal/gastric varices, ascites, hepatic encephalopathy)
- Have lost more than 11 pounds within the 3 months prior to screening
- Have a hemoglobin A1c (HbA1c) greater than 10%
- Have type 1 diabetes
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2032
Estimated Enrollment :
4500 Patients enrolled
Trial Details
Trial ID
NCT07165028
Start Date
October 15 2025
End Date
August 1 2032
Last Update
December 24 2025
Active Locations (554)
Enter a location and click search to find clinical trials sorted by distance.
1
MFA Clinical Research
Tuscaloosa, Alabama, United States, 35405
2
The Institute for Liver Health II dba Arizona Clinical Trials - Chandler
Chandler, Arizona, United States, 85224
3
Spectrum Research Institute
Gilbert, Arizona, United States, 85297
4
The Institute for Liver Health II dba Arizona Liver Health - Peoria
Peoria, Arizona, United States, 85381